Adaptive by Design


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Product Description

Adaptive trial designs have the potential to speed development and reduce overall costs — that is, if sponsors invest in up-front planning and can implement these designs correctly.
Interest in adaptive designs has risen in recent years. These types of studies involve a broad class of methods and can have a positive impact on any program across the ­different stages of ­development. Experts say the flexibility of an adaptive design allows sponsors to make course corrections during a trial based on interim data. But experts stress these changes should be preplanned decisions based on simulations and ­­well-thought out, up-front planning.

The Potential

Our experts discuss how adaptive designs address the challenge of getting new products to the market faster and with…

Sound Bites From The Field
Melissa Hammond
is Managing Director of Snowfish, which provides insights to healthcare, life-sciences, and biotechnology companies. For more information, visit
Andrea Perrone, M.D.
, is VP, Clinical Operations and Medical Director at BioClinica Inc., a global provider of integrated, technology-enhanced clinical trial management services. For more information, visit
Jason Rock
is Chief Technical Officer at GlobalSubmit, a developer of software designed exclusively for the review and validation of electronic common technical document (eCTD) global submissions. For more information, visit

The FDA Draft Guidance
The Adaptive Process

Randy Anderson, Ph.D. VP, Global ­Product Development, PPD Inc., a global contract research organization. For more information, visit
Molly Blake-Michaels. Director of Clinical Services, ClearTrial, a provider of clinical trial operations software. For more information, visit, or e-mail
Susan Bornstein. Executive VP, eClinical Solutions, which provides clinical data management and consulting services. For more information, visit, or e-mail
Michael Boyd, Ph.D. Senior Director, Global Biostatistics, INC Research, a therapeutically focused contract research ­organization. For more information, visit
Sylva Collins, Ph.D. VP, E-Clinical Solutions, Aris Global, which provides drug safety monitoring, pharma­covigilance, regulatory compliance, and clinical trials management software. For more information, visit ­
Jennifer Dudinak, Pharm.D. Global Head, Inflammation, Regulatory Affairs, Roche, a research-focused healthcare company, which has combined strengths in pharmaceuticals and ­diagnostics. For more information, visit
Brenda Gaydos, Ph.D. Senior Research ­Advisor, Eli Lilly and Company, which is developing pharmaceutical products by applying the latest research from its own ­worldwide laboratories and from collaborations. For more information, visit
Mary F. Johnson, Ph.D. Executive VP, ­Biostatistics, PharmaNet Development Group Inc., a global drug development services company that ­provides a comprehensive range of services. For more information, visit
Bryan Luce, Ph.D. Senior VP, United BioSource Corp., a global medical affairs and research ­organization. For more information, visit ­
Olga Marchenko. Global Head of Data Services Therapeutic Consulting, i3 ­Statprobe, which is the clinical data services ­division of i3. For more information, visit
Judith Quinlan. VP, Adaptive Clinical Trials, Cytel Inc., which is a provider of adaptive clinical trial design services and specialized statistical ­software. For more information, visit
Bill Sietsema, Ph.D. VP, Regulatory Consulting and Submissions, Kendle, a global full-service ­clinical research organization. For more information, visit